Clinical Trial: To Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Double-blind, Two Dose Group, Parallel-control Multi-center, Post-marketing Clinical Trial,to Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Pre
Brief Summary: A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.
Detailed Summary:
Research purpose： To evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.
Research design： A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial.
Sample size:
A total of 288 subjects, 144cases in each group.
Therapeutic schedule:
- Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.
- High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.
Usage and Dosage:
Oral ,1bag each time, 3 times a day, 4 weeks for 1 course of treatment.
Drug combination:
During the test shall not merge the other anti-arrhythmic drugs beyond the provisions of this scheme. Due to merger disease or condition changes ,have to use drugs or other treatment, investigators must record the types (or other treatment ),drug usage, time and reasons, in order to summarize ,analyze and report.
Primary indicator:
24 h dynamic electrocardiogram (Holter): before treatment, after treatment of 4 w, each record at a time.
Secondary Indicator:
Symptom sco
Sponsor: Beijing Bozhiyin T&S Co., Ltd.
Current Primary Outcome: 24 h dynamic electrocardiogram (Holter) [ Time Frame: Baseline, up to 4 weeks, each record at a time. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Symptom scores [ Time Frame: Baseline, up to 4 weeks, each record at a time. ]
Original Secondary Outcome: Same as current
Information By: Beijing Bozhiyin T&S Co., Ltd.
Dates:
Date Received: December 2, 2014
Date Started: January 2015
Date Completion: February 2017
Last Updated: July 22, 2015
Last Verified: July 2015
